Life Science

Product quality and pro­cess re­lia­bi­lity is es­sen­tial in re­gards of phar­ma­ceu­ti­cal water. LAR ana­ly­zers de­ter­mine con­ta­mi­na­tion re­li­ably in lowest levels meeting inter­na­tio­nal re­por­ting re­quire­ments.

Life Science

 

Water analysis of pharmaceutical water, as Purified Water (PW), Highly Purified Water (HPW) or Water for Injection (WFI) is of special concern in the life science industry regarding product quality and safety in process.

Depending on the res­pec­tive ap­pli­ca­tion, re­quire­ments re­gar­ding UPW purity are de­fined in norms as well as pharma regulations (pharmacopoeia).

 

 

Types of Water

  • Process water
  • Pure water (PW)
  • Highly purified water (HPW)
  • Water for injections (WFI)
  • Ultra-pure water (UPW)

Process Control and Product Safety

Types of Pharmaceutical Water and their Limitations

Depending on its usage pharmaceutical water needs treatment with various filters and/or disinfection (see the schematic pharma water system above). Generally, there are three types of pharma water defined, :

  • Purified Water (PW) or Aqua Purificata
  • Highly Purified Water (HPW) or Aqua Valde Purificata
  • Water for Injection (WFI) or Aqua Ad Iniectabilia

International Pharmacopeias

In pharma industry the production of Purified Water (PW) and the maximum TOC (total organic carbon) level is defined by more than one authority.

The most popular pharmacopeias are:

  • Chinese Pharmacopoeia (CP),
  • European Pharmacopoeia (EP),
  • Indian Pharmacopoeia (IP),
  • Japanese Pharmacopoeia (JP), and
  • U.S. Pharmacopeial Convention (USP).

In the pharmaceutical sector water is inter alia used as

  • Cleaning agent
  • Excipient
  • Ingredient
  • Raw material and much more

Depending on its usage, pharmaceutical water needs a certain purity. 
Requirements on water quality and monitoring equipment are high.

  • Water for injections (WFI) is a demanding application of UPW in the pharmaceutical industry. In the manufacture of any type of active ingredient and medicine, the entire production process, including the cleaning process, is seamlessly monitored.
  • Highly purified water (HPW) is used as cleaning agent
  • Ultra-pure water (UPW) is often used as process water for the production of pills, capsules and other oral medication.

Purification of water

  • Even drinking water or potable water contain organics and other substances in very low concentration
  • pharmaceutically used water needs to be purified before it is used in manufacturing processes
  • The treatment of this so-called feedwater or make-up water takes place on-site and is very costly

Comparison of phamaceutical water Limits

 

Purified Water

Highly Purified Water

   Water for Injection

TOC    

USP

EP

     USP

  EP

  USP

EP

   500 ppb    

≤ 0,5 mg/l    

   N/A

    ≤ 0,5 mg/l

   500 ppb

  ≤ 0,5 mg/l

  • TOC Analyzer for Pharma Applications

    LAR's tailor-made total organic carbon analyzer QuickTOCpharma fulfills the special requirements of the pharma industry.

    Features & benefits:

    • Highest thermal oxidation power at 1,200°C that easily oxidizes the bad-to-oxidize standard p-benzoquinone (part of the SST test)
    • Software conforming to FDA (CFR 21 Chapter 11)
    • Instant validation at any time
    • Measurement within < 3 min
    • According to USP Chapter <643> and EP 2.2.44
  • Types of Pharmaceutical Water and their Limitations

    Depending on its usage pharmaceutical water needs treatment with various filters and/or disinfection (see the schematic pharma water system above). Generally, there are three types of pharma water defined, :

    • Purified Water (PW) or Aqua Purificata
    • Highly Purified Water (HPW) or Aqua Valde Purificata
    • Water for Injection (WFI) or Aqua Ad Iniectabilia
  • International Pharmacopeias

    In pharma industry the production of Purified Water (PW) and the maximum TOC (total organic carbon) level is defined by more than one authority.

    The most popular pharmacopeias are:

    • Chinese Pharmacopoeia (CP),
    • European Pharmacopoeia (EP),
    • Indian Pharmacopoeia (IP),
    • Japanese Pharmacopoeia (JP), and
    • U.S. Pharmacopeial Convention (USP).

 

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